RU2013133714A - Моноклональные антитела человека к белку программируемой смерти 1 (pd-1) и способы лечения рака с использованием анти-pd-1-антител самостоятельно или в комбинации с другими иммунотерапевтическими средствами - Google Patents
Моноклональные антитела человека к белку программируемой смерти 1 (pd-1) и способы лечения рака с использованием анти-pd-1-антител самостоятельно или в комбинации с другими иммунотерапевтическими средствами Download PDFInfo
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Abstract
1. Моноклональное антитело или его антигенсвязывающая часть, которое перекрестно конкурирует за связывание с белком программируемой смерти (PD-1) со ссылочным антителом или его антигенсвязывающей частью, где ссылочное антитело или его антигенсвязывающая часть содержит:а) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:1, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:8;b) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:2, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:9;с) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:3, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:10;d) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:4, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:11;e) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:5, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:12;f) вариабельную область тяжелой цепи, содержащуюаминокислотную последовательность SEQ ID NO:6, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:13;g) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:7, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:14.2. Моноклональное антитело или его антигенсвязывающая часть, по п. 1 которое связывается с т�
Claims (33)
1. Моноклональное антитело или его антигенсвязывающая часть, которое перекрестно конкурирует за связывание с белком программируемой смерти (PD-1) со ссылочным антителом или его антигенсвязывающей частью, где ссылочное антитело или его антигенсвязывающая часть содержит:
а) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:1, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:8;
b) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:2, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:9;
с) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:3, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:10;
d) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:4, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:11;
e) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:5, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:12;
f) вариабельную область тяжелой цепи, содержащую
аминокислотную последовательность SEQ ID NO:6, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:13;
g) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:7, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:14.
2. Моноклональное антитело или его антигенсвязывающая часть, по п. 1 которое связывается с тем же эпитопом PD-1 что и ссылочное антитело или его антигенсвязывающая часть, где ссылочное антитело или его антигенсвязывающая часть содержит:
а) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:1, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:8;
b) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:2, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:9;
с) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:3, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:10;
d) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:4, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:11;
e) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:5, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:12;
f) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:6, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:13;
g) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:7, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:14.
3. Моноклональное антитело или его антигенсвязывающая часть по п. 1, где ссылочное антитело или его антигенсвязывающая часть содержит:
(a) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:4; и
(b) вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:11.
4. Моноклональное антитело или его антигенсвязывающая часть по п. 1, содержащее:
(а) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность, полученную из последовательности гена VH 3-33 зародышевой линии, и/или вариабельную область легкой цепи, содержащую аминокислотную последовательность, полученную из последовательности гена Vκ L6 зародышевой линии; или
(b) вариабельную область легкой цепи, содержащую аминокислотную последовательность, полученную из последовательности гена VH 4-39 зародышевой линии, и/или вариабельную область легкой цепи, содержащую аминокислотную последовательность, полученную из последовательности гена Vκ L15 зародышевой линии.
5. Моноклональное антитело или его антигенсвязывающая часть по п. 1, которое содержит:
(а) последовательность CDR1 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:15, или ее вариант с консервативными заменами; последовательность CDR2 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:22, или ее вариант с консервативными заменами; последовательность CDR3 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:29, или ее вариант с консервативными заменами; последовательность CDR1 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:36, или ее вариант с консервативными заменами; последовательность CDR2 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:43, или ее вариант с консервативными заменами; последовательность CDR3 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:50, или ее вариант с консервативными заменами;
(b) последовательность CDR1 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:16, или ее вариант с консервативными заменами; последовательность CDR2 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:23, или ее вариант с консервативными заменами; последовательность CDR3
тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:30, или ее вариант с консервативными заменами; последовательность CDR1 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:37, или ее вариант с консервативными заменами; последовательность CDR2 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:44, или ее вариант с консервативными заменами; последовательность CDR3 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:51, или ее вариант с консервативными заменами;
(c) последовательность CDR1 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:17, или ее вариант с консервативными заменами; последовательность CDR2 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:24, или ее вариант с консервативными заменами; последовательность CDR3 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:31, или ее вариант с консервативными заменами; последовательность CDR1 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:38, или ее вариант с консервативными заменами; последовательность CDR2 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:45, или ее вариант с консервативными заменами; последовательность CDR3 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:52, или ее вариант с консервативными заменами;
(d) последовательность CDR1 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:18, или ее вариант с консервативными заменами; последовательность CDR2 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:25, или
ее вариант с консервативными заменами; последовательность CDR3 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:32, или ее вариант с консервативными заменами; последовательность CDR1 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:39, или ее вариант с консервативными заменами; последовательность CDR2 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:46, или ее вариант с консервативными заменами; последовательность CDR3 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:53, или ее вариант с консервативными заменами;
(e) последовательность CDR1 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:19, или ее вариант с консервативными заменами; последовательность CDR2 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:26, или ее вариант с консервативными заменами; последовательность CDR3 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:33, или ее вариант с консервативными заменами; последовательность CDR1 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:40, или ее вариант с консервативными заменами; последовательность CDR2 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:47, или ее вариант с консервативными заменами; последовательность CDR3 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:54, или ее вариант с консервативными заменами;
(f) последовательность CDR1 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:20, или ее вариант с консервативными заменами; последовательность CDR2 тяжелой цепи,
содержащую аминокислотную последовательность SEQ ID NO:27, или ее вариант с консервативными заменами; последовательность CDR3 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:34, или ее вариант с консервативными заменами; последовательность CDR1 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:41, или ее вариант с консервативными заменами; последовательность CDR2 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:48, или ее вариант с консервативными заменами; последовательность CDR3 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:55, или ее вариант с консервативными заменами; или
(g) последовательность CDR1 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:21, или ее вариант с консервативными заменами; последовательность CDR2 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:28, или ее вариант с консервативными заменами; последовательность CDR3 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:35, или ее вариант с консервативными заменами; последовательность CDR1 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:42, или ее вариант с консервативными заменами; последовательность CDR2 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:49, или ее вариант с консервативными заменами; последовательность CDR3 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:56, или ее вариант с консервативными заменами.
6. Моноклональное антитело или его антигенсвязывающая часть по п. 5, которое содержит:
(a) последовательность CDR1 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:18, или ее вариант с консервативными заменами;
(b) последовательность CDR2 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:25, или ее вариант с консервативными заменами;
(с) последовательность CDR3 тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:32, или ее вариант с консервативными заменами;
(d) последовательность CDR1 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:39, или ее вариант с консервативными заменами;
(e) последовательность CDR2 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:46, или ее вариант с консервативными заменами;
(f) последовательность CDR3 легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:53, или ее вариант с консервативными заменами.
7. Моноклональное антитело или его антигенсвязывающая часть по п. 1, которое содержит:
(а) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:1, или ее вариант с консервативными заменами, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:8, или ее вариант с консервативными заменами;
(b) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:2, или ее вариант с
консервативными заменами, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:9, или ее вариант с консервативными заменами;
(c) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:3, или ее вариант с консервативными заменами, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:10, или ее вариант с консервативными заменами;
(d) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:4, или ее вариант с консервативными заменами, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:11, или ее вариант с консервативными заменами;
(e) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:5, или ее вариант с консервативными заменами, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:12, или ее вариант с консервативными заменами;
(f) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:6, или ее вариант с консервативными заменами, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:13, или ее вариант с консервативными заменами;
(d) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:7, или ее вариант с консервативными заменами, и вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:14, или
ее вариант с консервативными заменами.
8. Моноклональное антитело, или его антигенсвязывающая часть по п. 7, содержащее:
(а) вариабельную область тяжелой цепи, содержащую аминокислотную последовательность SEQ ID NO:4, или ее вариант с консервативными заменами; и
(b) вариабельную область легкой цепи, содержащую аминокислотную последовательность SEQ ID NO:11, или ее вариант с консервативными заменами.
9. Моноклональное антитело, или его антигенсвязывающая часть по любому из пп. 1-8, которое является химерным или гуманизированным антитело или его частью.
10. Моноклональное антитело, или его антигенсвязывающая часть по любому из пп. 1-8, которое является антителом человека или его частью.
11. Моноклональное антитело, или его антигенсвязывающая часть по любому из пп. 1-8, которое связывается с PD-1 человека, экспрессируемым на клеточной поверхности.
12. Моноклональное антитело, или его антигенсвязывающая часть по любому из пп. 1-8, которое ингибирует супрессию CD4+ CD25- T-клеток регуляторными Т-клетками.
13. Моноклональное антитело, или его антигенсвязывающая часть по п. 2, которое усиливает антиген-специфичную ответную реакцию памяти на опухоль или патоген.
14. Моноклональное антитело, или его антигенсвязывающая часть по любому из пп. 1-8, которое обеспечивает постоянный иммунитет к опухолевому рецидиву.
15. Моноклональное антитело, или его антигенсвязывающая часть по любому из пп. 1-8, которое представляет собой антитело IgG1 или IgG4 или его часть.
16. Моноклональное антитело, или его антигенсвязывающая часть по п. 15, которое представляет собой IgG4 и не обладает ни ADCC активностью, ни CDC активностью.
17. Моноклональное антитело, или его антигенсвязывающая часть по любому из пп. 1-8, где часть антитела выбрана из фрагмента Fab, F(ab')2, Fv или dAb, CDR или одноцепочечного Fv (scFv).
18. Иммуноконъюгат, содержащий моноклональное антитело или его антигенсвязывающую часть, по любому из пп. 1-17, связанное с терапевтическим агентом.
19. Иммуноконъюгат по п. 18, где терапевтическим агентом является цитотоксин или радиоактивный изотоп.
20. Биспецифическая молекула, содержащая моноклональное антитело или его антигенсвязывающую часть по любому из п.п. 1-17, связанное со второй функциональной частью молекулы, имеющей другую специфичность связывания, чем указанное антитело или его антигенсвязывающая часть.
21. Композиция, содержащая фармацевтически приемлемый носитель и:
(а) моноклональное антитело или его антигенсвязывающую часть по любому из пп. 1-17;
(b) иммуноконъюгат по п. 18 или 19; или
(c) биспецифическую молекулу по п. 20.
22. Выделенная молекула нуклеиновой кислоты, кодирующая
антитело или его антигенсвязывающую часть по любому из пп. 1-17.
23. Вектор экспрессии, содержащий молекулу нуклеиновой кислоты по п. 22.
24. Клетка-хозяин, содержащая вектор экспрессии по п. 23.
25. Гибридома, полученная из трансгенной мыши, содержащей трансгены тяжелой и легкой цепей иммуноглобулина человека и экспрессирующей моноклональное антитело по любому из п.п. 1-8 и 9-16, где гибридома продуцирует моноклональное антитело.
26. Способ модуляции иммунной реакции у индивида, предусматривающий введение индивиду моноклонального антитела или его антигенсвязывающей части по любому из пп. 1-17.
27. Способ ингибирования роста опухолевых клеток у индивида, предусматривающий введение индивиду моноклонального антитела или его антигенсвязывающей части по любому из пп. 1-17.
28. Способ по п. 27, где опухолевые клетки являются клетками рака, выбранными из меланомы, рака почек, рака простаты, рака молочной железы, рака толстой кишки и/или рака легкого.
29. Способ по п. 27, где опухолевые клетки являются клетками рака, выбранными из перечня, состоящего из костного рака, рака поджелудочной железы, рака кожи, рака головы и шеи, кожной или внутриглазной злокачественной меланомы, рака матки, рака яичника, ректального рака, рака анальной области, рака желудка, рака яичек, рака матки, рака фаллопиевых труб, рака эндометрия, рака шейки матки, рака вагины, рака вульвы, болезни Ходжкина, не-Ходжкинской лимфомы, рака пищевода, рака тонкой кишки, рака эндокринной системы, рака щитовидной железы, рака паращитовидной железы, рака надпочечника, саркомы мягкой ткани, рака
мочеиспускательного канала, рака пениса, хронических или острых лейкозов, включая острый миелоидный лейкоз, хронического миелоидного лейкоза, острого лимфобластного лейкоза, хронического лимфоцитарного лейкоза, солидных опухолей детского возраста, лимфоцитарной лимфомы, рака мочевого пузыря, рака почки или мочеточника, рака почечных лоханок, неоплазмы центральной нервной системы (ЦНС), лимфомы первичной ЦНС, ангиогенеза опухоли, опухоли спинного мозга, глиомы ствола мозга, аденомы гипофиза, саркомы Капоши, эпидермоидного рака, плоскоклеточного рака, Т-клеточной лимфомы, индуцированных условиями окружающей среды раковых заболеваний, включая раковые заболевания, индуцированные асбестом, и комбинаций указанных типов рака.
30. Способ лечения инфекционного заболевания у индивида, предусматривающий введение индивиду моноклонального антитела или его антигенсвязывающей части по любому из пп. 1-17.
31. Способ по п. 30, где инфекционное заболевание представляет собой:
(а) заболевание, выбранное из гриппа, герпеса, гиардиоза, малярии, лейшманиоза;
(b) патогенную инфекцию, вызываемую вирусом, выбранным из вируса иммунодефицита человека (ВИЧ), вируса гепатита, герпесвируса, аденовируса, вируса гриппа, флавивируса, эховируса, риновируса, вируса Коксаки, коронавируса, респираторно-синцитиального вируса, вируса эпидемического паротита, ротавируса, вируса кори, вируса краснухи, парвовируса, вирус осповакцины, HTLV-вируса, вируса Денге, папилломавируса,
вируса контагиозного моллюска, полиовируса, вируса бешенства, JC-вируса и вируса арбовирусного энцефалита;
(с) патогенную инфекцию, вызываемой бактериями, выбранными из хламидии, бактерии рода Rickettsia, микобактерии, стафилококка, стрептококка, пневмококка, менингококка и конококка, клебсиелы, протеуса, серации, псевдомонад, легионеллы, дифтерийной бактерии, сальмонеллы, бациллы, возбудителя холеры, возбудителя столбняка, возбудителя ботулизма, возбудителя сибирской язвы, возбудителя чумы, возбудителя лептоспироза и бактерии, вызывающие болезнь Лайма;
(d) патогенную инфекцию, вызываемой грибами, выбранными из Candida, Cryptococcus neoformans, Aspergillus, рода Mucorales, Sporothrix schenkii, Blastomyces dermatitidis, Paracoccidioides brasiliensis, Coccidioides immitis и Histoplasma capsulatum; или
(e) патогенную инфекцию, вызываемую паразитами, выбранными из Entamoeba histolytica, Balantidium coli, Naegleriafowleri, Acanthamoeba sp., Giardia lambia, Cryptosporidium sp., Pneumocystis carinii, Plasmodium vivax, Babesia microti, Trypanosoma brucei, Trypanosoma cruzi, Leishmania donovani, Toxoplasma gondi и Nippostrongylus brasiliensis.
32. Способ усиления иммунной реакции на антиген у индивида, предусматривающий введение индивиду:
(i) антигена; и
(ii) моноклонального антитела или его антигенсвязывающей части по любому из пп. 1-17, таким образом, что иммунная реакция на указанный антиген у индивида усиливается.
33. Способ по п. 32, где антигеном является опухолевый
антиген, вирусный антиген, бактериальный антиген или антиген из патогена.
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| ES2384168T3 (es) * | 2002-04-12 | 2012-07-02 | Medarex, Inc. | Procedimientos de tratamiento usando anticuerpos CTLA-4 |
| SI2206517T1 (sl) | 2002-07-03 | 2023-12-29 | Ono Pharmaceutical Co., Ltd. | Imunopotencirni sestavki,ki obsegajo protitelesa proti PD-L1 |
| ATE493433T1 (de) | 2002-09-11 | 2011-01-15 | Genentech Inc | Neue zusammensetzung und verfahren zur behandlung von immunerkrankungen |
| DE10347710B4 (de) | 2003-10-14 | 2006-03-30 | Johannes-Gutenberg-Universität Mainz | Rekombinante Impfstoffe und deren Verwendung |
| CN103059138B (zh) | 2005-05-09 | 2015-10-28 | 小野药品工业株式会社 | 程序性死亡-1(pd-1)的人单克隆抗体及使用抗pd-1抗体来治疗癌症的方法 |
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